Q-Switched Nd:YAG Laser System
K-Number: K172908 · 2017-12-07
ApplicantAmi, Inc.
Decision Date2017-12-07
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Q-Switched Nd:YAG Laser System is a medical device manufactured by Ami, Inc.. It received FDA 510(k) clearance on 2017-12-07 under approval number K172908. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Q-Switched Nd:YAG Laser System?
Q-Switched Nd:YAG Laser System is a medical device that received FDA 510(k) clearance on 2017-12-07. It is manufactured by Ami, Inc.. The 510(k) number is K172908.
When was Q-Switched Nd:YAG Laser System approved by the FDA?
Q-Switched Nd:YAG Laser System received FDA 510(k) clearance on 2017-12-07, under approval number K172908.
What company makes Q-Switched Nd:YAG Laser System?
Q-Switched Nd:YAG Laser System is manufactured by Ami, Inc..
What is the FDA product code for Q-Switched Nd:YAG Laser System?
The FDA product code for Q-Switched Nd:YAG Laser System is GEX. This falls under the Gastroenterology category.
Related Clinical Trials
NCT07607496
MacuTherm Performance Study in Patients With iAMD
NOT_YET_RECRUITING
NCT07101809
Trial of Ureteroscopy vs Steerable Continuous Flow Aspiration Technology
RECRUITING
NCT07214220
Intravascular Neuro OCT Imaging System for Aneurysm Treatment Evaluation
RECRUITING
NCT07579611
Efficacy of Spinal Cord Stimulation in Chemotherapy-Induced Peripheral Neuropathy
NOT_YET_RECRUITING
NCT07580560
Aqua Therapeutics Thermal Therapy Vapor Ablation System (ATTTVAS) Abnormal Uterine Bleeding Safety Study
COMPLETED
NCT06795451
Modulating Spinal Interoceptive Pathways to Evaluate Their Role and Therapeutic Potential in MDD Symptomatic Domains
RECRUITING
Other Devices by Ami, Inc.
Related Devices (Code: GEX)
K162114Photon, Photon PlusZolar Technology & Mfg Co., Inc.
K161632FAMILY OF SQUARE EPIL (Alex, Alex2, Nd:Yag, Alex+Nd:Yag)Bios S.R.L.
K163222Discovery Pico FamilyQuanta System Spa
K163009LithoQuanta System Spa
K162191NAVILAS Laser SystemOd-Os GmbH
K162363V30 system, V-Form Handpiece BC Medium applicatorViora , Ltd.
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.